Full Press Release Details
to Treat Advanced Liver Cancer Patients with Namodenoson Under Compassionate Use Setting in Israel
TIKVA, Israel, August 6, 2019 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with
a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today that a supply
of Namodenoson has been manufactured and is ready for use in the treatment of advanced liver cancer patients under compassionate
use at the Rabin Medical Center in Israel.
use allows doctors and their patients the option of early access to investigational new drugs, under closely controlled and monitored
circumstances, when a patient who is facing serious illness has exhausted all available treatment options.
M. Stemmer, MD, the Principal Investigator of the Company's prior Phase II liver cancer study said, "Given the evidence
of clinical benefit of Namodenoson in patients with hepatocellular carcinoma and Child Pugh B7 to whom there is no accepted well
established treatment, I plan to offer Namodenoson to certain HCC CPB7 patients in the compassionate use setting."
recently announced results from its Phase II study of Namodenoson in the treatment of advanced liver cancer. Namodenoson was found
to increase overall survival in HCC patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo,
even though the trial did not meet its primary endpoint.
end of Phase II meeting with the U.S. Food and Drug Administration to review study data and to present the design of a Phase III
clinical trial is expected soon. The FDA has granted Namodenoson both Orphan Drug and Fast Track status providing a pathway for
accelerated approval based on unmet need in the treatment of advanced liver cancer. Fast Track designation offers advantages
including more frequent meetings with the FDA and rolling review, which provides the opportunity to submit parts of its New Drug
Application (NDA) for review prior to completing the entire application for commercialization. Orphan Drug designation includes
7-year market exclusivity following marketing approval, FDA assistance during the drug development process, and exemption
of application fees.
is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson
is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment
for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells
whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology
that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's
liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of
liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted
Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food
and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate,
and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical
studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These
drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information
please visit: www.can-fite.com.
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